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510(k) K853841

HARMO SONIC by U.S. Shizai Corp. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1986
Date Received
September 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

Other clearances by U.S. Shizai Corp.

  • K822464 — OBTURATION GUTTA (November 3, 1982)
  • K820639 — OBTURATION SYSTEM KIT (April 9, 1982)
  • K802189 — DENTLOID (September 26, 1980)
  • K800951 — CASTA-LLOY (May 8, 1980)

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